RecruitingNAINTERVENTIONAL

Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a common condition where organs like the bladder or womb drop into the vagina, causing discomfort and other issues. Current treatments often include pessaries, which are inserts that support these organs. However, many women struggle with existing pessaries as they often don't fit well, can cause irritation, or are hard to manage. This study introduces a new type of pessary, designed to naturally fit each woman's unique shape and be easier to use and care for at home. Researchers will compare this new device to traditional pessaries to see if it's more effective, comfortable, and preferred by patients. The goal is to offer a better solution for women living with POP.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

30 Apr 2026

Estimated completion

01 Oct 2026

Pelvic Organ Prolapse (POP)

What is this study about?

Pelvic organ prolapse (POP) is a common health issue for many women, especially as they get older. It happens when organs in the pelvis, such as the bladder, womb (uterus), or bowel, start to drop down and press into the vagina. This can lead to uncomfortable feelings like pressure or a bulge, and can cause problems like leaking urine, difficulty with bowel movements, or pain during sex. It's a condition that can really impact a woman's daily life and confidence.

One common treatment, besides surgery, is using a pessary. A pessary is a small, removable device that’s placed inside the vagina to hold the organs in their correct position. Think of it like a support. While pessaries can be very helpful for many, the current ones have some downsides. They come in fixed sizes, so about 3 out of 10 women can't find one that fits comfortably. If a pessary doesn't fit well or isn't cleaned regularly, it can cause soreness, bleeding, or just feel uncomfortable. Because of these problems, nearly half of women who start using a pessary stop within the first year.

This study is testing a brand-new type of pessary that aims to solve these problems. This new device is designed to naturally match the shape of a woman's body and can even be custom-made for an individual. It's also expected to be much easier for women to put in and take out themselves. The researchers believe this new, personalisable pessary could offer a more comfortable and effective solution. Participants in the study will try out this new pessary for three months and share their experiences, including how their symptoms feel and how easy and comfortable the new pessary is to use. The hope is that this new design could lead to better treatment options for women with POP in the future.

Key takeaways

Pelvic organ prolapse is common and can affect daily life.
Current pessary treatments have fit and comfort issues for many women.
This study tests a new, custom-fit pessary designed for better comfort and ease of use.
Participants will use the new pessary for three months and share their experiences.
The goal is to find a better, more personalised solution for POP treatment.

Who may be eligible?

This study is looking for women who have symptoms of pelvic organ prolapse (POP) and are already using a pessary for at least three months. You need to be at least 18 years old and able to understand and speak English well to participate. You also need to be able to give informed consent, which means you fully understand what the study involves and agree to take part.

There are several reasons why someone might not be able to join the study. For example, if you are pregnant or planning to get pregnant in the next six months, you cannot take part. If your vagina is very short or narrow, or if you have any open sores, wounds, or infections in the vaginal or anal area, you also wouldn't be able to join.

The study also excludes people who have certain medical conditions like inflammatory bowel disease, ongoing treatment for cancers near the pelvic area, or specific chronic pain conditions affecting the pelvis. If you've had pelvic floor surgery in the last 12 months, or have any significant medical issues that might make it hard to participate in the study, you would also be unable to join. The research team will carefully check everyone against these criteria to ensure the study is safe and suitable for participants.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman at least 18 years old?
Do you currently have pelvic organ prolapse symptoms?
Are you already using a pessary for at least three months?
Can you understand and speak English well?
Are you not pregnant or planning pregnancy in the next 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here’s what you can expect:

**Switching Pessaries:** You will switch from your current pessary to the new, custom-fit pessary and use it for a period of three months.

**Questionnaires:** You will be asked to fill out questionnaires about your POP symptoms. These help the researchers understand how your symptoms change and how you're feeling with the new pessary.

**Feedback:** You will also provide feedback on how comfortable the new pessary is and how easy you find it to use and manage yourself.

**No New Medication:** You won't be given any new medications as part of this study; it's focused on the pessary device itself.

**Total Duration:** The main part of your involvement will last for three months while you use the new pessary and provide your feedback.

Potential risks and benefits

Taking part in this study could offer you several benefits, such as potentially finding a more comfortable and easier-to-manage pessary that improves your POP symptoms and quality of life. You'll also be contributing to important research that could help many other women with POP in the future. As with any medical device, there are potential risks, though. The new pessary might not fit perfectly, or it could still cause some discomfort, irritation, or other issues, similar to traditional pessaries. The researchers will be monitoring you closely for any problems. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Dale Sheard Centre for Solutions in Women's Health
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What is pelvic organ prolapse (POP)?

POP is when organs like your bladder or womb drop down into your vagina, causing uncomfortable symptoms.

What is a pessary for POP?

A pessary is a removable device inserted into the vagina to support pelvic organs and relieve POP symptoms.

Why is a new pessary needed?

Current pessaries often don't fit well or cause discomfort, leading many women to stop using them. A better design is needed.

What's special about this new pessary?

It's custom-fit to your body's natural shape and aims to be easier for you to manage yourself.

How long would I be in the study?

If you join, you would use the new pessary and provide feedback for about three months.

How to find out more

May Sanaee, BSc MD FRCSC MHScEd

sanaee@ualberta.ca 1-780-735-5290 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.